FDA 510(k) Application Details - K213930

Device Classification Name	More FDA Info for this Device
510(K) Number	K213930
Device Name	Brainlab Elements Guide XT, Guide 3.0
Applicant	Brainlab AG Olof-Palme-Str.9 Munich 81829 DE Other 510(k) Applications for this Company
Contact	Chiara Cunico Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2021
Decision Date	04/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review